Duke University Medical Center (DUMC) serves as a local and regional referral Center for AIDS related malignancies. In addition to providing conventional chemotherapy to patients with AIDS related malignancies, we have developed a program for treating patients with AIDS related lymphoma with two novel forms of therapy: 1) adoptive immunotherapy with EBV specific Cytotoxic T-cells and 2) myeloablative chemotherapy/radiotherapy and hematopoietic stem cell transplantation. These pilot clinical protocols are based on ongoing scientific studies conducted within the DUMC Molecular Therapeutics Program and the DUMC Center for AIDS Research by grant investigators. Patients enrolled in these protocols are followed in a dedicated multidisciplinary AIDS Lymphoma Clinic. To support these novel forms of therapy, DUMC has recently entered into an agreement with ExVivo Therapies, Inc. to develop a state of the art facility for performing ex-vivo cell processing according to FDA guidelines and Good Manufacturing Practices. This facility is an invaluable resource for conducting adoptive immunotherapy and stem cell transplantation clinical trials at DUMC and will be available for use by members of the NCI consortium. We have a wide array of clinical and laboratory resources available to support NCI Consortium clinical trials involving treatment of other AIDS related malignancies. These resources include an extensive regional referral network, the DUMC Adult Infectious Disease Clinic, a dedicated AIDS Women' clinic, the Duke Comprehensive Cancer Center, the DUMC Bone Marrow Transplant Service, and the DUMC General Clinical Research Unit. We have extensive prior experience in designing and conducting Phase I- III clinical trials in the HIV field and have a substantial infrastructure in place to conduct trials involving novel therapies for AIDS related malignancies. This includes a Virologic Core Laboratory and Immunology Core Laboratory within the Centers for AIDS Research for performing state of the art measurements of the effects of therapies on HIV viral burden and on general and specific aspects of the immune system. In summary, our patient population and scientific expertise make DUMC an ideal candidate to join the NCI Consortium for AIDS Associated Malignancies.
